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Footwear

Orthofeet Shoes for Plantar Fasciitis

Phase 1 & 2
Waitlist Available
Research Sponsored by Bijan Najafi, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 week, 6 weeks, 7 weeks, 12 weeks
Awards & highlights

Study Summary

This trial is testing a new type of pain-relieving footwear to see if it increases daily activity levels and improve functional performance.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 week, 6 weeks, 7 weeks, 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 week, 6 weeks, 7 weeks, 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Foot Pain Intensity
Change in step count from baseline to 6 weeks to 12 weeks
Secondary outcome measures
Change in Balance
Change in Cognitive Function
Change in Fear of Falling
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Orthofeet ShoesExperimental Treatment1 Intervention
Participants will be given Orthofeet shoes to wear for 6 weeks
Group II: No Orthofeet shoesActive Control1 Intervention
This group will not be wearing Orthofeet shoes for 6 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Orthofeet Shoes
2022
Completed Phase 2
~50

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Bijan Najafi, PhDLead Sponsor
4 Previous Clinical Trials
284 Total Patients Enrolled
Orthofeet, Inc.UNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential harm could be caused by wearing Orthofeet Shoes?

"With prior clinical data supporting Orthofeet Shoes' safety, their risk assessment was graded as a 2. This study is in its second phase and has not yet yielded enough evidence to support effectiveness."

Answered by AI

What is the sample size in this clinical research study?

"Affirmative. According to the information listed on clinicaltrials.gov, this medical experiment is actively seeking applicants and was originally posted in June 2022 with its last update occurring in October of that same year. The trial requires at least 50 patients from a single centre for enrolment purposes."

Answered by AI

Is this research endeavor looking to enroll new participants at present?

"According to information posted on clinicaltrials.gov, this research is actively seeking participants. The trial was first published in June 15th 2022 and recently revised on October 11th 2022."

Answered by AI

Does this research include participants over forty years of age?

"This clinical trial has established a minimum age of 50 and an upper limit of 85 for potential participants."

Answered by AI

What are the criteria for individuals to qualify for participation in this trial?

"Those who wish to take part in this trial must have a foot ailment and be between the ages of fifty and eighty-five. Approximately 50 people will be admitted into the study."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
Texas
How old are they?
18 - 65
What site did they apply to?
Baylor College of Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
~18 spots leftby Apr 2025